RU2843620C1 - Method for replacing an extended circular tracheal defect - Google Patents

Abstract

FIELD: medical science.

SUBSTANCE: invention refers to medicine, namely to thoracic surgery. Extended circular tracheal defect is replaced stepwise. At the first stage, two fragments of the small intestine with vascular pedicles are separated. Electric coagulation is used to remove a mucosal layer with obliterating the lumens of the small intestinal fragments. Then fragments of small intestine are wrapped around spiral-wire titanium nickelide prosthesis in semi-rings, sewing them serous-muscular sutures. Prepared graft is placed into an abdominal cavity for 7 days. At the second stage, the graft is removed from the abdominal cavity with preserving vascular pedicles. Graft is delivered subcutaneously and fixed with interrupted sutures on the proximal and distal edges of the tracheal defect.

EFFECT: method enables restoring the trachea continuity and normalizing the air passage function, reducing a risk of infectious complications.

1 cl, 9 dwg, 2 ex

Description

Field of technology to which the invention relates

The invention relates to medicine, thoracic surgery, namely to reconstructive surgery of the trachea, and can find application in replacing an extended circular defect.

State of the art

Currently, the number of cases of extended tracheal defects is increasing due to the widespread use in medical practice of various methods of respiratory resuscitation, artificial ventilation, tracheostomy [1], as well as an increase in the number of resection interventions on the trachea, as a result of which the problem of replacing these defects is becoming increasingly relevant.

There are many areas of research in the field of replacing extended tracheal defects: artificial prostheses made of natural or synthetic materials; allografts obtained from human donors; autografts, and tissue-engineered implants. The results of using existing tracheal reconstruction methods in clinical practice are ambiguous and far from ideal for the following reasons: growth of granulation tissue in the area of "prosthesis-tissue" contact, occurrence of chronic inflammation or infectious complications, formation of erosions and tracheoesophageal fistulas. Success in tracheal defect reconstruction depends on the characteristics of the material and its interaction with surrounding tissues. The most widely used prostheses are made of polytetrafluoroethylene (PTPE), however, studies of long-term results show a significant percentage of purulent complications due to the presence of the porous structure of the implant, and biodegradation processes of the implant are also noted [2].

Experiments are currently being conducted in the field of creating bioengineered implants based on pluripotent stem cells [3], [Patent of the Russian Federation for Utility Model RU 125464 U1, A61F 2/20, published 2013.03.10].

However, these developments are associated with significant implementation costs, a long waiting period for the matrix to be populated by cells (3-6 weeks) and are at the preclinical testing stage.

A method is known for forming a combined transplant for replacing circular defects of the trachea, consisting of a pericardial autograft and a mesh structure made of superelastic nickel-titanium thread [Patent of the Russian Federation for invention RU 2445008 C1, A61B 17/00, published 20.03.2012]. The complexity of implementation is associated primarily with the need to collect a section of the pericardium, which significantly expands the required scope of intervention.

An implant for plastic surgery of tracheoesophageal fistula is known, made in the form of a flap of skin-fascial tissue on a vascular pedicle [Patent of the Russian Federation for Utility Model RU 27470 U1, A61B 17/00, published 10.02.2003].

The known above methods do not solve the problem of closing an extended defect, in particular a circular defect, since they do not involve the creation of a rigid framework.

A method of tracheal transplantation is known, which includes the use of a fragment of the small intestine on a feeding vascular pedicle as a transplant, reinforcing the fragment by suturing a frame into the intestinal wall from the outside with immersion serous-muscular sutures, characterized in that steel wire is used to reinforce the wall, curved in the form of a semi-spiral with transverse sections between the semi-rings, the arches of the semi-spiral are located on the side opposite the mesentery, and the part without arches is on the side of the mesentery [Patent of the Russian Federation for Utility Model RU 2306877 C1, A61B 17/00, A61F 2/04, published 09/27/2007].

The disadvantage of this method is the contact of the intestinal mucosa with non-sterile inhaled air, which manifests itself as persistent inflammation followed by the formation of scar tissue.

The closest to the claimed method is the method consisting in collecting and forming a free revascularized tubular intestinal autograft, suturing it into the tracheal defect, restoring the blood supply in the autograft, and then externally strengthening it with a reinforcing device. In this case, a meander spiral that is at least 10 mm longer than the autograft is used as the reinforcing device. The spiral is made of superelastic titanium nickelide wire with a rough surface with a longitudinal direction of transmission of its waves [Topolnitsky E.B., Dambaev G.Ts., Gunter V.E. Method for replacing an extended circular tracheal defect. Russian Federation Patent for Utility Model RU 2449740 C1, IPC A61B 17/00. No. 2011109477/14; declared. 14.03.2011; published 10.05.2012, Bulletin No. 13].

The disadvantage of this method is the direct contact of the intestinal mucosa with the lumen of the trachea, which leads to the development of chronic inflammation and, as a consequence, the formation of fibrous and granulation tissue, which causes deformation of the reconstructed organ, stenosis of the lumen and disruption of its function.

Disclosure of invention

The objective of the invention is to create a more effective method for closing an extended tracheal defect by replacing a section of the airways (a segment of the trachea) with material taken from the patient, namely fragments of the small intestine on feeding vascular pedicles with the serous membrane inside, with reinforcement of the fragment with a wire prosthesis made of titanium nickelide.

The technical result of the proposed invention is the restoration of the continuity of the trachea and the normalization of the air passage function, reducing the risks of infectious complications.

The specified technical result is achieved in a method for replacing an extended circular defect of the trachea, including the step-by-step formation of a transplant, in which:

at the first stage, two fragments of the small intestine are isolated on feeding vascular pedicles, the mucous layer is removed using electrocoagulation, obliterating the lumens of the fragments of the small intestine, then the fragments of the small intestine are wrapped in half rings around a spiral wire prosthesis made of titanium nickelide, stitching them with serous-muscular sutures, and the transplant is placed in the abdominal cavity for 7 days;

At the second stage, the transplant is removed from the abdominal cavity while preserving the feeding vascular pedicles, inserted subcutaneously and fixed with interrupted sutures at the proximal and distal edges of the tracheal defect.

The proposed method is aimed at reducing the risks of infectious complications due to contact of the serous membrane of the intestine with inhaled air containing a significant amount of pathogenic and opportunistic flora.

Thus, the positive effect of the invention is achieved through the use of:

- stainless wire made of medical material - nickel-titanium alloy, which has shape memory. The alloy creates a frame, is inert, and is able to take the shape given to it in the range of body temperatures of mammals;

- properties of the peritoneum, which include: protective (antibacterial activity of the peritoneum, partially suppressing the development of pathogenic microflora), plastic (when the surface is damaged, fibrous exudate is released, gluing the serous surfaces in contact with each other, and causing rapid organization of the gluing site and its transformation into a connective tissue adhesion - rapid tissue regeneration.

Another advantage of this method over known ones is the absence of foreign agents that cause an immune reaction, and therefore, complete engraftment of the transplant.

Brief description of illustrations

The invention is explained by drawings and diagrams.

Fig. 1 shows the stage of isolation of two fragments of the small intestine on the feeding vascular pedicle.

Fig. 2 shows a horizontal section of the transplant, consisting of two fragments of the small intestine, sewn with serous-muscular sutures, secured to a spiral-wire prosthesis, where:

1 - spiral-wire prosthesis;

2 - intestinal segment 1;

3 - mesentery;

4 - obliterated intestinal lumen;

5 - intestinal segment 2;

6 - graft lumen.

Fig. 3 shows the final appearance of the tracheal defect replaced by the transplant.

The technique of the first stage is shown in Fig. 4 - Fig. 9.

Fig. 4 shows the isolation of a loop of the jejunum, the formation of 2 segments on feeding vascular pedicles with treatment of the mucous membrane of the segments with monopolar coagulation in the “spray” mode, and suturing of the stumps.

Fig. 5 shows the formation of a side-to-side isoperistaltic ileo-ileoanastomosis.

Fig. 6 shows the verification of the diameter and length of the wire prosthesis made of titanium nickelide for compliance with the formed intestinal fragments.

Fig. 7 shows the formation of a transplant using a continuous serous-muscular suture on the intestinal segments using a 5/0 Vicryl thread on a piercing needle (formation of the posterior wall).

Fig. 8 shows the reinforcement of the transplant with a wire prosthesis made of titanium nickelide, suturing the anterior wall with a continuous seromuscular suture.

Fig. 9 shows the final appearance of the transplant.

Implementation of the invention

The verification test of the technical result achievability is the experimental testing of the proposed method of replacing circular defects of the thoracic trachea on 2 laboratory pigs of the hybrid mini-pig breed weighing 80 kg and 76 kg. The animal experiments were performed in the vivarium of the Department of Topographic Anatomy of the Federal Autonomous Educational Institution of Higher Education First Moscow State Medical University named after I.M. Sechenov of the Ministry of Health of the Russian Federation (Sechenov University).

The study was conducted in accordance with the ethical principles set out in the "European Convention for the Protection of Vertebrate Animals used for Experimental and other Scientific Purposes". All manipulations were performed under two-component anesthesia, and animals were euthanized by carbon dioxide inhalation.

Two experiments on the replacement of circular tracheal defects were conducted in two stages. The implant exposure at the first stage was 1 week, at the second - 1 week. The animals were withdrawn from the experiment 14 days after the second stage.

Animals underwent tracheoscopy before withdrawal from the experiment. Dynamic observation of animals was conducted, and the condition of the prosthetic section of the trachea was assessed macroscopically during autopsy.

Technique of the first stage:

Under two-component anesthesia (Xylazine 20 mg/ml at a dosage of 8-10 mg/kg, administered intramuscularly, and the drug Ketamine 50 mg/ml at a dosage of 35 mg/kg, administered intramuscularly, and premedication carried out with the drug Atropine 0.1% at a dosage of 0.04 mg, also administered intramuscularly), a laparotomy is performed, two fragments of the small intestine are isolated (together with the vascular pedicle and the corresponding section of the mesentery), an entero-enteroanastomosis is applied in order to restore the continuity of the intestinal tract, then the mucous membranes are removed from the isolated fragments of the small intestine by monopolar coagulation in the "spray" mode, a spiral wire prosthesis made of titanium nickelide is prepared with a size and shape corresponding to the tracheal defect (a tracheal defect of 30 mm is formed in the second stage, a tracheal diameter of 20 mm). A spiral wire prosthesis made of titanium nickelide is placed in the abdominal cavity, fragments of the small intestine are wrapped around it in half rings and sutured with serous-muscular sutures. A visual assessment of the viability of the transplant is carried out (absence of signs of ischemia, color change), and the laparotomy wound is sutured layer by layer.

Technique of the second stage:

On the 7th day, animals undergo relaparotomy under the two-component anesthesia described above, the transplant is removed on the feeding vascular pedicles, carried out subcutaneously to the trachea area, where a 30 mm segment of the trachea is removed at one time, the defect is replaced with a transplant and fixed in the proximal and distal parts with separate interrupted sutures. The wounds are sutured layer by layer. The condition of the transplant is assessed tracheoscopically after 14 days.

Examples of implementation of the invention

The invention is confirmed by clinical examples.

Example 1

In the laboratory: a laboratory pig of the mini-pig breed, female, 1 year old, healthy, of normal size, weighing 80 kg. Two operations were performed in accordance with the above-described technology. The animal's condition immediately after the 1st stage of the experiment is satisfactory, breathing independently. After 1 week, the animal is active, eating independently, stool is normal, postoperative wounds heal by primary intention, breathing is normal. As part of the second stage of the experiment, a graft was isolated from the abdominal cavity, a section of the trachea was resected to create a defect, and the tracheal defect was replaced with a graft. Evaluation of the graft condition after 14 days: during tracheoscopy - the graft has no signs of inflammation, the serous membrane of the intestine is covered with loose fibrin.

Example 2

In the laboratory: laboratory pig of the mini-pig breed, male, 11 months old, healthy, normal size, body weight 76 kg. Two operations were performed in accordance with the above-described technology, similar to example 1. However, when assessing the condition of the transplant after 14 days by tracheoscopy, signs of subsiding local edema in the area of the proximal anastomosis were revealed, the serous membrane of the intestine with areas of diapedetic hemorrhages is covered with loose fibrin. The morphological picture is assessed as a local inflammatory reaction within the framework of convalescence and can be corrected with medication.

The results of the anatomical experiment and experimental testing on animals confirm the efficiency of the proposed method and the achievability of the technical result. The readiness of the operation for clinical use indicates that the proposal meets the criterion of "industrially applicable".

LIST OF USED SOURCES

1. Osipov A.S., Gasanov A.M., Pinchuk T.P. Postintubation trophic injuries of the larynx and trachea. Endoscopic diagnostics, prevention and treatment. Surgery. Journal named after N.I. Pirogov. 2011; (4): 68-72.

2. Flessenkämper I., Müller K.M. Biodegradation einer PTFE-Prothese [Biodegradation of a PTFE prosthesis]. Zentralbl Chir. Feb 2001; 126 (2): 151-5; discussion 155-6. German. doi:10.1055/s-2001-12417. PMID: 11253541.

3. Kiselevsky M.V., Anisimova N.Yu., Shepelev A.D., Tenchurin T.Kh., Mamagulashvili V.G., Krasheninnikov S.V., Grigoriev T.E., Lebedinskaya O.V., Chvalun S.N., Davydov M.I. Mechanical properties of a bioengineered tracheal prosthesis based on a synthetic ultrafibrous matrix // Russian Journal of Biomechanics. 2016. No. 2.

Claims (1)

A method for replacing an extended circular tracheal defect that includes a step-by-step formation of a transplant, in which: at the first stage, two fragments of the small intestine are isolated on feeding vascular pedicles, the mucous layer is removed using electrocoagulation, obliterating the lumens of the small intestinal fragments, then the small intestinal fragments are wrapped in half rings around a spiral-wire prosthesis made of titanium nickelide, suturing them with serous-muscular sutures, and the transplant is placed in the abdominal cavity for 7 days; at the second stage, the transplant is removed from the abdominal cavity while preserving the feeding vascular pedicles, carried out subcutaneously and fixed with interrupted sutures at the proximal and distal edges of the tracheal defect.